BEUDAMED
    FDA Adverse Event Other Summary report: N

    TDCH, 4L, 110CM, CATHETER HTR KIT

    MDR report key: 1833101 · Received May 11, 2010

    Report

    Report Number
    2025816-2010-00044
    Event Type
    Other
    Date Received
    May 11, 2010
    Date of Event
    April 28, 2009
    Report Date
    April 30, 2009
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    COMPLAINT REC'D. REPORTING TWO (2) 41229-02 CATHETER BALLOON INFLATION FAILURES. THE INFORMATION REC'D. STATED THE DEVICES WERE SUCCESSFULLY PRE-TESTED AND INSERTED WITH NO PROBLEMS NOTED. IN THE FIRST INCIDENT "THE CLINICIAN COULDN'T FLOAT THE CATHETER AFTER INSERTION AND ULTIMATELY....SUSPENDED THE RA-RV." IN THE SECOND INCIDENT, THE DEVICE WAS SUCCESSFULLY FLOATED, "AT SOME POINT LATER IN THE PROCEDURE, AN ATTEMPT TO RE-INFLATE THE BALLOON WAS UNSUCCESSFUL... AN ECHOCARDIOGRAM WAS ALREADY SCHEDULED FOR THE NEXT DAY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES OR DELAY IN CRITICAL THERAPY IN EITHER OF THESE TWO CASES." A REVIEW OF THE MFG LOT DATABASE FOR THE REPORTED LOT# 63-366-SN (MFG. DATE 03/2008) SHOWS (B)(4). CONCLUSION: THE INVOLVED 41229-02 CATHETER DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND CONFIRMATION. EXACT CAUSE(S) OF THE EVENT ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDCH, 4L, 110CM, CATHETER HTR KIT PA CATHETER DYG ICU MEDICAL, INC. 41229-02 63-366-SN

    Patients

    Seq Age Sex Outcome Treatment
    1